Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue
Prosthesis Guided Speech Rehabilitation of T1/T2 Cancers of the Tongue (PGSRT): a Randomized Clinical Trial
University of Michigan
40 participants
Jan 2, 2018
INTERVENTIONAL
Conditions
Summary
This study will fill a scientific gap in the current knowledge providing data for evaluation of the palatal augmentation prosthesis (PAP) as a therapeutic modality post-surgery. This is a robust scientific randomized prospective clinical trial. Positive outcomes from this study have the potential to dramatically alter the most common issues of oral cancer therapy, namely speech and swallowing functions. Patients will have been diagnosed with a cancer lesion of the tongue requiring surgery and removal of part of the tongue. Smaller cancers of the tongue are sized as T1 or T2. For patients with smaller lesions, a PAP, which can aid in speaking and swallowing, is not routinely provided.
Eligibility
Inclusion Criteria1
- Patients with a new diagnosis of a T1/T2 tongue cancer
Exclusion Criteria3
- Patients with recurrent disease
- Patients with a history of prior head and neck radiation therapy
- Patients who lack adequate maxillary dentition to support a palatal augmentation prosthesis
Interventions
The palatal augmentation prosthesis, or PAP can improve speech and swallowing functions through reshaping the palatal contours. This may improve the contact between the tongue and hard palate as a person speaks or eats. It is meant to be created after adequate healing in patients with adequate motivation for improvements in their speech and swallowing. Regular wear and articulation therapy are necessary for this therapy to be effective.
Subjects will receive the standard of care speech and articulation therapy in either arm.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT02584270